NCT00399724

Brief Summary

Primary objective:

  • To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia. Secondary objectives:
  • To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia.
  • To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms.
  • To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment.
  • To obtain safety data on the use of insulin glargine in each treatment algorithm.
  • To measure change in subject weight and insulin dose between baseline and end of treatment.
  • To determine subject quality of life and treatment satisfaction (sub-study)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,376

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
Last Updated

August 31, 2010

Status Verified

August 1, 2010

Enrollment Period

1.4 years

First QC Date

November 14, 2006

Last Update Submit

August 30, 2010

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Incidence of severe hypoglycaemia

Secondary Outcomes (15)

  • Incidence of any hypoglycaemia

  • Incidence of symptomatic hypoglycaemia

  • Incidence of nocturnal hypoglycaemia

  • Incidence of asymptomatic hypoglycaemia

  • Adjusted mean change in Hb1Ac (%)

  • +10 more secondary outcomes

Interventions

Insulin glargineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with Type 2 Diabetes Mellitus,
  • Subjects on antidiabetic treatment (oral and/or insulin therapy) for \> 6 months,
  • Subjects who require a basal long-acting insulin for the control of hyperglycaemia,
  • HbA1c values \> 7.0% and \< 12 %,
  • BMI \< 40 kg/m².
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Davies M, Lavalle-Gonzalez F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.

    PMID: 18355327RESULT

  • Davies M, Sinnassamy P, Storms F, Gomis R; AT.LANTUS Study Group. Insulin glargine-based therapy improves glycemic control in patients with type 2 diabetes sub-optimally controlled on premixed insulin therapies. Diabetes Res Clin Pract. 2008 Feb;79(2):368-75. doi: 10.1016/j.diabres.2007.09.013. Epub 2007 Nov 5.

    PMID: 17980928RESULT

  • Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.

    PMID: 15920040RESULT

  • Khunti K, Srinivasan BT, Shutler S, Davies MJ. Effect of insulin glargine on glycaemic control and weight in obese and non-obese people with type 2 diabetes: data from the AT.LANTUS trial. Diabetes Obes Metab. 2010 Aug;12(8):683-8. doi: 10.1111/j.1463-1326.2010.01217.x.

    PMID: 20590745DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Patrick Sinnassamy, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 14, 2006

First Posted

November 15, 2006

Study Start

March 1, 2002

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

August 31, 2010

Record last verified: 2010-08